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Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure (IronHeart)

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ClinicalTrials.gov Identifier: NCT03871699
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Hospital Moinhos de Vento

Brief Summary:

In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease. Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial.

It is unknown if iron deficiency is correlated with intra-myocardial iron load as assessed by cardiac magnetic resonance (CMR) and if the treatment with intravenous iron has any impact on intra-myocardial iron load and left ventricular function.

The aim of the present study is to evaluate the effect of intravenous iron replacement on intra-myocardial iron deposits and the effect on left ventricular function.

Because it is a pilot study with few data in the literature, it is planned to use an initial sample of 20 patients.

We aim to evaluate the global ventricular function, the iron load by the T2 * method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient by CMR. After this examination, patients will undergo intravenous infusion of 1g of Ferric Carboxymaltose (Ferinject®).

A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment.

The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin <100 μg / L or with ferritin 100-299 μg / L with transferrin saturation <20 %; Hemoglobin <12g / dL in women and <13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) <40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: patients with preserved ejection fraction (> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).


Condition or disease Intervention/treatment Phase
Cardiac Failure Systolic Heart Failure Heart Failure, Systolic Drug: Ferric carboxymaltose Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Ferric Carboximaltose on Intra-myocardial Iron Load Assessed by Cardiac Magnetic Resonance in Patients With Heart Failure With Reduced Ejection Fraction (HFREF).
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Experimental: Iron Reposition
The selected patients will receive 1g of ferric carboxymaltose applied intravenously after dilution in 100ml of crystalline solution. the infusion time will be around 15 minutes realized at the moinhos the vento infusion center.
Drug: Ferric carboxymaltose
Administration of Ferric Carboxymaltose intravenously, one dose only.
Other Name: Ferrinject




Primary Outcome Measures :
  1. Absolut changes in left ventricular ejection fraction [ Time Frame: 30 days ]
    Compare the left ventricular ejection fraction 30 days after receiving 1g of ferric carboxymaltose intravenously.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Left ventricular ejection fraction <40% assessed by transthoracic echocardiography or cardiac magnetic resonance with at least 3 months.

  • Serum ferritin < 100µg/L or 100-299µg/L with transferrin saturation < 20%
  • clinical stability during last 3 months

Exclusion Criteria:

  • Use of intracardiac defibrillator or pacemaker.
  • Severe to moderate valvar heart disease
  • Clinical instability, acute coronary syndrome and cardiac surgery within 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871699


Contacts
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Contact: Luis Beck da Silva, MD ScD +5551997330870 luisbeckdasilva@gmail.com
Contact: Luciano Giordani, MD lucianogiordani@gmail.com

Locations
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Brazil
Hospital Moinhos de Vento Not yet recruiting
Porto Alegre, RS, Brazil, 90440050
Contact: LUIS BECK DA SILVA, MD    +5551997330870    luisbeckdasilva@gmail.com   
Contact: CARISI A POLANCZYK, MD    +555133143434    CARISI.POLANCZYK@hmv.org.br   
Principal Investigator: LUIS BECK DA SILVA, MD ScD         
Sponsors and Collaborators
Hospital Moinhos de Vento
Takeda
Investigators
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Principal Investigator: Luis Beck da Silva, MD ScD Hospital Moinhos de Vento
Study Director: Luciano Giordani, MD Hospital Moinhos de Vento
Study Director: Carisi A Polanczyk, MD ScD Hospital Moinhos de Vento
Study Director: Paulo R Schvartzman, MD ScD Hospital Moinhos de Vento

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Responsible Party: Hospital Moinhos de Vento
ClinicalTrials.gov Identifier: NCT03871699     History of Changes
Other Study ID Numbers: IronHeart
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hospital Moinhos de Vento:
Heart
Failure
Iron
Deficiency
Systolic
Reduced
Ejection
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Ferric Compounds
Hematinics